FDA approves ICOTYDE, first oral IL-23 receptor peptide, for plaque psoriasis

The FDA approved ICOTYDE (icotrokinra), a once-daily oral peptide that blocks the IL-23 receptor, for moderate-to-severe plaque psoriasis in adults and patients aged 12 and older weighing at least 40 kg. In head-to-head studies about 70% of patients reached clear or almost clear skin at week 16, and 55% achieved PASI 90. The launch is J&J's main answer to STELARA erosion in immunology, and partner Protagonist Therapeutics receives a $50 million milestone.

• About 70% of patients reached IGA 0/1 (clear or almost clear skin) at week 16 in head-to-head studies
• 55% of patients achieved PASI 90 at week 16
• Approval rests on Phase 3 studies that included about 2,500 patients
• Partner Protagonist Therapeutics receives a $50 million milestone payment